Office of Pharmaceutical Quality: Removing Barriers to Innovation
Christine M. V. Moore, PhD
Global Head and Executive Director, GRACS CMC - Policy
Merck Research Laboratories, United States
The Office of Pharmaceutical Quality (OPQ) provides a uniform drug quality program with “one quality voice” across all drug product areas in CDER – new drugs, biotechnology products, generic drugs, and over-the-counter drugs. Many changes and innovation have occurred since the January 2015 stand up of the office. This sessionwill discuss some of the innovative approaches being used within OPQ to better streamline review efficiency, integrate review and inspection, and maintain knowledge over a product’s lifecycle.
Learning Objective : Explain the roles of the different offices within the Office of Pharmaceutical Quality (OPQ) and understand the ongoing initiatives to improve the review and inspection processes.